Executive Director/Head of Clinical
Operations, #1446

(oncology / immuno-oncology focus)

 

 

Position #:                     #1446
Therapeutic Area:         Oncology / Immuno-oncology              
Recruiting Status:          Retained Exclusive Search
Classification:                Full-time Permanent position
Location:                       Greater Gaithersburg, Maryland area
Relocation Assistance? Yes
Why Available?              New position
Company size:               Small but part of a larger organization
 

 

EXPERIENCE – KEY AREAS

  • Clinical Trials Industry experience

  • Immuno-oncology or oncology experience

  • Management experience

 

 

POSITION SUMMARY

The Executive Director, Head of Clinical Operations will oversee all aspects of clinical trial operations including supervision of Clinical Trial Managers (CTMs), CRO/vendor selection, developing appropriate SOPs to ensure trials are conducted in compliance with regulatory requirements, and training for Clinical Operations staff. The Executive Director, Head of Clinical Operations will also be responsible for planning and obtaining adequate resources, finalization of budgets and will work with Senior Management when input is necessary.  This position reports to the Chief Medical Officer.

 

Responsibilities

  • Oversees all aspects of clinical operations and directly supervises all CTMs

  • Leads the overall conduct of all clinical programs.

  • Ensures all programs under his/her oversight are conducted in accordance with applicable SOPS, ICH, GCP and other regulatory requirements.

  • Provides clinical support for required regulatory submission, such as annual reports, updating of the IB, and final study reports.

  • Develops departmental SOPs and works with Quality Assurance for compliance with applicable quality and regulatory requirements.

  • Provides strategic clinical development input and routine updates regarding the status of programs to Senior Management.

  • Plans and obtains adequately resource, trains and develops the clinical operations staff.

  • Conducts annual performance evaluations for direct reports.

 

Qualifications and Skills ​​

  • Degree in a life science, nursing qualification or relevant experience

  • Candidate should have a minimum of 7 years’ experience in the clinical research industry, with a minimum of 5 years direct experience in planning and managing clinical studies.

  • Related experience working in the Oncology or Immuno-Oncology therapeutic area

  • Excellent working knowledge of ICH, GCP and FDA guidelines/regulations.

  • Excellent managerial, organizational and negotiation skills.

  • Excellent verbal and written communication skills.

  • Solid understanding of the drug development process with a special emphasis on clinical operations.

  • Proven track record of success in a leadership role.

  • Energetic individual, eager to manage multiple activities and priorities.

  • Dedication to quality in all work tasks and deliverables

 

WORKING CONDITIONS

  • Approximately 20% travel may be required

  • In-office position with occasional home office 

 

DIRECT REPORTS

  • Clinical Trial Project Managers

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Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.

 

NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.

 

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